职位描述

职位描述： Education/QualificationsBachelor’s Degree or aboveBiology, Microbiology, Biochemistry, Pharmacy or other relevant discipline is preferredExperience (may vary depending on site size/scope)At least 4 years’ experience in Microbiology Lab of major or joint venture Pharma CompanyExperience of lab management, or lean lab, or QA/QS is preferredJob Required CompetenciesProfessional knowledge of microbiology and bioassay analysis Knowledge of cGMP relevant to the pharmaceutical industry Knowledge of laboratory safetyTeamwork spirit and cross functional communication skills Excellent verbal and written communication skills in EnglishYou’re ensuring that all tasks performed comply with Roche PQS and applicable regulations such as GMP, GLP and Pharmacopeias.Complete assigned routine testing tasks; issue reliable analytical reports in reasonable lead time.Master microbial analytical methods, including Growth promotion test, Bioburden test, Microbial limit test, Sterility test, Endotoxin test, Environment monitoring methods and microorganism identification and etc.Comply with professional morality and etiquette to ensure reliability and integrity of the analytical data.Implement the maintenance and calibration of assigned instruments to meet the analytical needsCan lead qualification and validation tasks, e.g. equipment qualification, method validation and etc.Support the management of reagents and consumables in the lab, including media, strains, and etc.Report the abnormal status, unexpected results with initiative and in time.Can lead OOS/Deviation investigation process and provide solutions to prevent the same issue happened repeatedly.Strictly follow SHE rules in the lab to ensure the safety of personnel and security of lab..Assist Lab Manager to conduct GMP Self-Inspection and define follow-up CAPAs to maintain the global level of GMP compliance in the lab.Assist Lab Manager to manage samples, reference standards, and documentations.Handle lab related quality systems, such as OOS, DMS, CSV, Change Control and CAPAs.Can guide and train other analysts on testing skills and instrument management. 职能类别： 其他

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